The present invention relates generally to the field of inhalation devices, and more specifically, to a mouthpiece adaptor and patient feedback for an inhaler. The invention has particular utility as a mouthpiece adaptor and patient feedback for inhalation devices such as dry powder inhalers (“DPIs”) for facilitating use of same by pediatric, geriatric and compromised patients, and will be described in connection with such utility, although other utilities are contemplated such as for use with metered dose inhalers (“MDIs”) and nebulizers.
Metered dose inhalers (MDIs) depend on delivery technique to deliver the proper amount of medication to the lungs. A properly delivered MDI medication depends on dexterity, coordination, timing, and practice. This can be a real problem when the patient is young, has coordination problems, or especially irritable airways.
An alternative to MDIs are dry powder inhaler devices (DPIs), which are activated by the patient's inspiratory effort, so that coordination is not a problem, although inhalation technique is still important. The drug is aerosolized by the airflow through a DPI created by the patient inhaling. DPI devices are easy to use and are thus suitable for most ages. Newer multidose types of powder devices have electronics which include dose counters, which enable patients to check whether or not they have taken a dose and warns them when the inhaler is running out of doses by showing them exactly how many doses remain. U.S. Pat. No. 6,142,146 to Abrams et al. discloses this type of device. However, dry powder inhalers require patients to inspire reasonably rapidly to inhale the dry powder, so these devices are not suitable for younger children and infants. Further, even if young children and infants could conform to the protocol for using the device, current devices have mouthpieces which are too cumbersome for these patients.
When dealing with bronchial diseases among children and infants, it is difficult to make the patient properly inhale the therapeutic substances necessary for treatment. When asthma makes its debut among infants and young children, typically at 8 months to 2.5 years, it is especially difficult to make a child or infant inhale the prescribed medical substances in the proper way. Children and infants have limited lung capacity and the force of a child's or infant's breath during inhalation (inhalation flow) is thus limited. This is even more apparent when the child or infant is suffering from asthma or other bronchial diseases. Parents also desire that the devices used for inhalation be as flexible as possible, as it is difficult to position the inhaler in a way that will allow proper inhalation by an infant.
For patients of limited or compromised inhalation capacity, inhalation therapy may be accomplished through the use of inhalation chambers. An inhalation chamber typically includes an inlet and fixture for a medicament dispenser, e.g., an MDI, and an expanded hollow body, which in the technical field of inhalers normally is called a “spacer” or inhalation chamber, having an outlet provided at the end remote from the inlet. An inhalation/exhalation valve, e.g., a one-way valve, typically is provided adjacent the outlet, and a mouthpiece is provided at the outlet. When such a device is used by older children or adults the mouthpiece is inserted between the teeth and the lips are closed around the mouthpiece. It is, however, not possible for young children and infants to hold such a mouthpiece between their lips. Moreover, these devices are constructed to be used by older children who have large lung capacity and who can inhale more forcefully. The inhalation/exhalation valves provided typically require a certain inhalation flow, which a child or infant is unable to generate, to open properly. Therefore, for satisfactory inhalation to be achieved by young children and infants, inhalation devices often are provided with a face mask.
However, some small children and infants find standard inhalation devices employing masks frightening, and, as a consequence, resist using them. Faced with strong resistance from children, many care-givers responsible for administering medication to children report a reluctance to offer air-borne drugs for use with standard inhalation devices employing masks on a regular basis. In addition, care-givers also report that even when attempted, the delivery of aerosol/gas medication to children is often sub-optimal because the child cries and/or forcibly removes the mask from their face before the medication is taken properly.
Many patients who cannot use MDIs or DPIs, even with inhalation chambers, are forced to use nebulizers. Nebulizers produce a cloud of medication by passing a jet of compressed air through a solution of a drug (jet nebulizers) or by dropping the drug solution onto a plate vibrating at high frequency (ultrasonic nebulizers). Nebulizers have the advantage of being able to be used by patients of all ages, including young babies, because coordination is unimportant. However, disadvantages of nebulizers include that they are cumbersome, expensive (both the machine and the drugs) and noisy; require a power source, typically lines (AC) current; treatment takes a long time, often around ten minutes; and young patients are required to wear a mask. The amount of drug delivered to the lungs is highly dependant on the breathing pattern of the patient. All these factors tie down the patient and care-giver.
Because nebulizers have the above problems, several devices have been developed in order to entice or teach children how to use MDIs or DPIs, so that a nebulizer is unnecessary. But, those devices designed for use by young children require a mask adaptor for the MDI or DPI. PCT Application No. 995398 to Watt and European Patent 667168 to Minar et al. disclose incentive systems of this type.
Quite apart from the foregoing, conventional MDIs and DPIs (and also inhalation chambers therefor) have mouthpieces sized for the adult population. Thus, conventional MDIs, DPIs and inhalation chambers therefor have mouthpieces that are too big to be comfortably used by small children and infants. Moreover, the mouthpieces of conventional MDIs, DPIs and spacers are primarily rectangular in shape, which is somewhat awkward, or at least unfamiliar, particularly to small children.